Cgmp

“You should immediately and comprehensively assess your company‘s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to (US) FDA requirements,” US FDA said.

Making Ranbaxy units cGMP compliant time consuming: Sun Pharma

Sun Pharma sees remediation process at erstwhile Ranbaxy facilities as a "time consuming" process even as it aims to bring at least one of the plants to conform to current good manufacturing practice regulations (cGMP) in the current fiscal.

Dr Reddy's board approves share buyback for Rs 1,569.4 cr

The share buyback offer comes at a time when the drug maker is facing heat from the US Food and Drug Administration (USFDA) for manufacturing norm violations at three of its plants.

Sun Pharma up 3%; details of warning letter not worrisome

On December 22, the USFDA made public the warning letter which states that inspection 483 mentioned 23 observations. Out of the 23 observations, 10 were related to the injectables facility, 4 were on the oral solids facility, 8 were related to quality control labs and 1 was on warehousing.

DRL gets US FDA warning letter for 3 Indian facilities

The three plants that were inspected were the Unit VI of Srikakulam Plant, Unit V at Telangana‘s Miryalaguda Taluk Plant and Unit VII at the Duvvada Plant in Visakhapatnam.

USFDA issues warning letter to Unimark Remedies

The significant violations included failure of the company to document production and analytical testing activities at the time they are performed, the USFDA said.

Sun Pharma issues profit warning for FY16

The consolidated profit in addition to revenue may also be adversely impacted due to certain expenses/ charges arising out of integration and remedial actions.

Wockhardt slumps 6% on 2 drugs recall in US

According to information on the US health regulator's website, 166 bottles of Captopril tablets of 50 mg strength are being recalled in the US. In case of Clarithromycin, the recall is for 50 bottles containing tablets of 500 mg strength.

Ranbaxy plunges 20% on USFDA ban on Toansa API plant

Toansa is the fourth unit of the company that is banned and added to consent decree. With this, all of the company's India-based plants supplying to US are banned.

USFDA issues warning to Jubilant Life over CGMP norms

The manufacturing facilities, Jubilant HollisterStier, LLC (JHS) located at Spokane, Washington state, was inspected between April 15 and May 10, 2013, the US Food and Drug Administration (USFDA) said in a warning letter to company's CEO Marcelo A Morales.

Ranbaxy surges 11% as US plant gets FDA clearance

In a statement, Ranbaxy said that its New Jersey-based Ohm Labs has received an Establishment Inspection Report (EIR) from the US drug regulator for its December 2012 inspection.

FY12 profit to be better than FY11: Dishman Pharma

Dishman's Managing Director JR Vyas expects its key clients Abbott's contribution to grow by 50%. He further expects some more product orders coming in from Abbott in FY13.

Nectar Lifesciences gets European nod for Punjab plant

Nectar Lifesciences has received European approval for its Cephalosporin APIs manufacturing facility at Derabassi in Punjab.

Cadila to see marginal impact of USFDA warning letter

Chirag Talati, pharma analyst at Espirito Santo Securities tells CNBC-TV18 that since the company does not generate any sales from the facility, and approval of the 18 ANDAs (Abbreviated New Drug Application) were not expected until FY13, FY12 margins will remain intact.